Funding for this research was provided by:
Stichting Onderzoeksfonds Catharina ziekenhuis (2018-7)
Received: 18 June 2020
Accepted: 15 April 2021
First Online: 4 May 2021
: The trial was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, the Netherlands. Clinical Trial Registration: Netherlands Trial Register (NL6433). The study will be performed in accordance with the Declaration of Helsinki (Fortaleza, Brazil, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice guidelines. Informed consent will be obtained from all study participants before randomization.
: This document does not contain personal data and consent for publication is not applicable. We are willing to provide a model consent form on request.
: The principal investigators have no financial or other competing interests for the overall trial.